# K973475: Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Nov 20, 1997 after 69 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896807 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960755: Cardiotherm Blood Cardioplegia Systems, Medtronic Cardiac Surgery, Medtronic, Inc. (1996) Summary page 1.
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989) Summary page 1.
- K941473: Maxima Plus Hollow Fiber Oxygenator, Medtronic Vascular (1995) Summary page 1.

## Indications for use
The Medtronic CardioTherm™ Blood Cardioplegia System, with or without Carmeda® BioActive Surface, is intended for use in procedures requiring the mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

Source page: https://510kreport.com/device/K973475
Methodology: https://510kreport.com/methodology